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Trial record 3 of 56 for:    "Lung Disease" | "Dalteparin"

Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

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ClinicalTrials.gov Identifier: NCT00480636
Recruitment Status : Completed
First Posted : May 31, 2007
Results First Posted : August 10, 2010
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Acute Deep Vein Thrombosis
Intervention Drug: Fragmin (dalteparin sodium )
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dalteparin
Hide Arm/Group Description Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Period Title: Overall Study
Started 102
Completed 83
Not Completed 19
Reason Not Completed
Death             12
Lost to Follow-up             4
Other             2
Lost to follow-up; subsequently died             1
Arm/Group Title Dalteparin
Hide Arm/Group Description Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants
Between 18 and 44 years 4
Between 45 and 64 years 58
>= 65 years 39
Unspecified 1
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
61.6  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
54
  52.9%
Male
48
  47.1%
1.Primary Outcome
Title Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
Hide Description Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
Time Frame Month 6 or End of Treatment (EOT) (up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Participants
43
2.Secondary Outcome
Title Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
Hide Description Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.
Time Frame Baseline through Month 6 or EOT (up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who received at least 1 dose of study treatment.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Participants
0
3.Secondary Outcome
Title Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)
Hide Description Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.
Time Frame Baseline through Month 6 or EOT (up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Participants
0
4.Secondary Outcome
Title Percent of Participants With and Without Pulmonary Embolism (PE)
Hide Description PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)
Time Frame Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. n = number of participants per PE status at observation.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Percent of participants
Baseline with PE (n = 16) 15.7
Baseline without PE (n = 82) 80.4
Baseline with missing information (n = 4) 3.9
Week 2 with PE (n = 7) 6.9
Week 2 without PE (n = 85) 83.3
Week 2 with missing information (n = 10) 9.8
Month 1 with PE (n = 3) 2.9
Month 1 without PE (n = 96) 94.1
Month 1 with missing information (n = 3) 2.9
Month 3 with PE (n = 1) 1.0
Month 3 without PE (n = 91) 89.2
Month 3 with missing information (n = 10) 9.8
Month 6 or EOT with PE (n = 3) 2.9
Month 6 or EOT without PE (n = 85) 83.3
Month 6 or EOT with missing information (n = 14) 13.7
5.Secondary Outcome
Title Number of Participants With Recurrent DVT
Hide Description Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits
Time Frame Month 6 or EOT (up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: Participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dalteparin
Hide Arm/Group Description Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
All-Cause Mortality
Dalteparin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dalteparin
Affected / at Risk (%)
Total   13/102 (12.75%) 
Cardiac disorders   
Cardiopulmonary failure  1  2/102 (1.96%) 
General disorders   
Disease progression  1  9/102 (8.82%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon neoplasm  1  1/102 (0.98%) 
Colorectal cancer  1  1/102 (0.98%) 
Neoplasm progression  1  1/102 (0.98%) 
Ovarian cancer  1  1/102 (0.98%) 
Vascular disorders   
Embolism  1  1/102 (0.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dalteparin
Affected / at Risk (%)
Total   0/102 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00480636     History of Changes
Other Study ID Numbers: A6301082
First Submitted: May 29, 2007
First Posted: May 31, 2007
Results First Submitted: May 25, 2010
Results First Posted: August 10, 2010
Last Update Posted: August 10, 2010